Australia Implementing Prior Approval for Minor Variations

Posted 25 September 2012 | By Louise ZornozaRegLink

Australia's Therapeutic Goods Administration (TGA) has announced planned amendments to the regulatory requirements for making minor variations to registered prescription drugs.

Minor variations include any changes not requiring clinical, nonclinical or quality data to be submitted to regulators, and are typically submitted to TGA under what is known as the Streamlined Submission Process.

Under TGA's newly amended regulatory requirements, minor variations will be classified as either Safety-Related Requests (SRRs) or Self-Assessable Requests (SARs) for variations that are not safety related, and both will require prior TGA approval. 

There will be a three-month transition period, during which the TGA will: 

  • not strictly enforce the requirement for prior approval given that sponsors may already be in the process of preparing applications under current requirements; and 
  • will give priority to new submissions in the amended SAR format over those submitted under the current requirements.  

The TGA will be issuing guidance on the new regulatory process.


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